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New therapeutic approach to Tourette Syndrome in children based on a study of the effectiveness and safety of magnesium and vitamin B6

New therapeutic approach to Tourette Syndrome in children based on a randomised placebo-controlled double-blind phase IV study of the effectiveness and safety of magnesium and vitamin B6

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN41082378
Enrollment
38
Registered
2008-09-30
Start date
2007-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette Syndrome Mental and Behavioural Disorders Tic disorders

Interventions

Patients will be randomsied to the following medication: 1. Magnesium pidolate 0.5 mEq/Kg/day, divided to be taken twice daily. This should not be taken in conjunction with calcium or dairy products.

Sponsors

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 7 - 14 years, either sex. This is the age bracket during which the natural course of the illness is most exacerbated. Before the age of 7 years, the tics may not yet have appeared (this generally occurs at the age of 5 - 7 years). After 14 years, symptoms tend to stabilise. 2. Informed consent of the child's parents or guardians, and reasoned agreement with the child 3. Clinical diagnosis of TS, according to Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria 4. Score of 40 or more on the YGTSS

Exclusion criteria

Exclusion criteria: 1. Severe attention deficit hyperactivity disorder (ADHD) or obsessive compulsive disorder (OCD), not clinically controlled 2. Autism 3. Unrelated depression 4. Allergy to acetylsalicylic acid (due to the excipients used)

Design outcomes

Primary

MeasureTime frame
The clinical diagnosis of TS will be confirmed, and the YGTSS score ascertained, so that the patient may be included in the study and any subsequent fall in the global score recorded (at t0 ,t1, t2, t3 and t4).

Secondary

MeasureTime frame
Metabolic changes in baseline and post-treatment PET will be recorded.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026